Appointment of a panel of service providers for iso 13485:2016 certification for nhls (5-year contract)

Appointment of a panel of service providers for ISO 13485:2016 certification for NHLS for a period of five (5) years. The scope includes: audit man-days determined by the SAPRAH approved service provider; following ISO 13485:2016 standard requirements; gap assessment audit; assessments at planned intervals per department plan or request; cost broken down per department; invoicing broken down by audit stages; assessing the Quality Management System (QMS) for NHLS Diagnostic Media Products X4 for ISO 13485:2016 requirements; contract proposed for 5 years.

Closing date: 20 October 2026 at 12:00pm

Queries deadline: 14 October 2026 at 16:00

Formal briefing: none will be held

A formal briefing session will not be held. Respondents with specific queries should email them to the NHLS employee indicated in the communication section (Ruth Springbok) before 16:00 on 14 October 2026.

Enquiries (bidding procedure and technical):

• Contact: Ruth Springbok
• Email: [email protected]

Queries before closing date must be submitted to Ruth Springbok before 16:00 on 14 October 2026.

After closing, communication on any matter relating to the RFQ response may be directed to Ruth Springbok at the same email address.

Submission method: email to [email protected]

Closing time: 20 October 2026 at 12:00pm

Bids must be submitted on the official forms provided, not re-typed.

All returnable sections must be signed, stamped and dated.

Returnable documents are classified as:

• Mandatory: failure to submit by closing date and time results in disqualification.
• Used for scoring: failure to submit results in an automatic score of zero for that criterion.
• Essential: failure to submit allows NHLS to request the documents by a set deadline; failure thereafter may result in disqualification.

Mandatory returnable documents:

• Section 4: Quotation Form
• Accreditation of the certification body

Returnable documents used for scoring:

• Proof of claim for Specific Goals points (Section 7)
• Company profile and verifiable reference letters/contracts confirming ISO 13485 certification work
• Reference letters or certification project records identifying IVD/medical device clients and scope
• CVs, auditor/lead auditor certificates, training records and evidence of relevant audit experience
• CVs, sector codes/competence records, training records and list of relevant audits performed
• Technical proposal, methodology, implementation plan and indicative deliverables/timelines
• Resource plan, auditor availability, geographic coverage and proposed scheduling approach
• At least three contactable client references, preferably from medical device/IVD organisations

Essential returnable documents:

• Section 1: SBD1 Form
• Section 5: Certificate of Acquaintance with RFQ Documents
• Section 6: RFQ Declaration and Breach of Law Form
• Section 7: Specific Goals Claim Form
• Section 8: Protection of Personal Information
• CSD Registration report
• Tax Compliance Certificate

Disqualification risks:

• Late submission, regardless of reason.
• Omitting or failing to sign any mandatory returnable document.
• Submitting a bid that includes documents or references relating to any other quotation or proposal.
• Collusion with other respondents.
• Attempting to canvas NHLS officers or employees between closing date and award.
• Material deviation from standard terms and conditions, unless alternatives are submitted on company letterhead and accepted by NHLS Legal Counsel.

Evaluation is conducted in six steps:

Step 1 – Administrative responsiveness: bid lodged on time, all returnable documents completed and returned, validity verified, bid signed by authorised respondent. Must be passed to proceed.

Step 2 – Substantive responsiveness: general and legislation qualification criteria met, pre-qualification requirements (Annexure A) included, priced offer present, material compliance with scope. Must be passed to proceed.

Step 3 – Technical pre-qualification and functionality:

• Mandatory requirement: bidder must be an accredited management system certification body with a valid scope of accreditation covering ISO 13485:2016, issued by SANAS or another accreditation body that is a signatory to the IAF Multilateral Recognition Arrangement (MLA). Evidence: valid accreditation certificate and current scope of accreditation.
• Functionality minimum threshold: 80 out of 100 points.

Functionality criteria and weights:

• Demonstrated ISO 13485 certification experience (25%): 5 years with 5 relevant clients = 25; 5 years with 3-4 clients = 20; 3-<5 years with 3 clients = 15; <3 years or limited evidence = 5; no relevant evidence = 0.
• Demonstrated IVD/medical device certification experience (20%): 5 comparable clients = 20; 3-4 comparable clients = 15; 1-2 comparable clients = 8; none = 0.
• Competence of proposed ISO 13485 auditors (20%): all qualified with 5 years relevant experience = 20; all qualified with 3-<5 years = 15; partial team compliance = 8; insufficient evidence = 0.
• Sector-specific competence of audit team (15%): strong IVD-specific competence across team = 15; medical-device competence with some IVD exposure = 10; general medical-device exposure only = 5; no demonstrated sector competence = 0.
• Proposed certification methodology (10%): comprehensive, clear and fully responsive = 10; adequate with minor gaps = 7; partially responsive = 4; inadequate/no methodology = 0.
• Capacity and resources to service NHLS DMP facilities (5%): fully demonstrated = 5; adequate but with limitations = 3; insufficient = 0.
• Performance on comparable certification contracts (5%): 3 or more satisfactory references = 5; 2 satisfactory references = 3; 1 satisfactory reference = 1; none = 0.

Step 4 – Final weighted scoring:

• Price: 80 points, using formula PS = 80(1 - (Pt - Pmin)/Pmin)
• Specific Goals: 20 points

Step 5 – Post-tender negotiations (if applicable): if price is not market-related, NHLS may negotiate sequentially with the highest, then 2nd and 3rd ranked bidders, or cancel the RFQ.

Step 6 – Award of business and conclusion of contract.

Validity period: 90 business days from closing date; bidders may be asked to extend validity on the same terms.

Scope: Appointment of a panel of service providers for ISO 13485:2016 certification for NHLS for a period of five (5) years.

Key requirements:

• Audit man-days to be determined by the SAPRAH approved service provider.
• Follow ISO 13485:2016 standard requirements.
• Conduct gap assessment audits.
• Assessments to be conducted at planned intervals as per each department plan or request.
• Cost of audits to be broken down per department, as audits will not be requested or conducted at the same time.
• Invoicing to be broken down by audit stages of the gap assessment.
• Assess the Quality Management System (QMS) for NHLS Diagnostic Media Products X4 for ISO 13485:2016 requirements, as outlined in Annexure A (tables 1-4).
• Contract period: 5 years.

The bidder must provide a clear and fully responsive certification methodology covering technical certification planning and implementation, including the applicable certification cycle (Stage 1, Stage 2, surveillance and recertification activities), management of nonconformities, reporting, certification decision-making, and communication with NHLS. The methodology is scored out of 10 points: comprehensive and fully responsive = 10; adequate with minor gaps = 7; partially responsive = 4; inadequate or no methodology = 0.

Experience and qualifications requirements:

• Demonstrated ISO 13485 certification experience (25% weight): preference given to bidders with at least five years' relevant certification experience. Scoring: 5 years with 5 relevant clients = 25; 5 years with 3-4 clients = 20; 3-<5 years with 3 clients = 15; <3 years or limited evidence = 5; no relevant evidence = 0. Evidence: company profile and verifiable reference letters/contracts confirming ISO 13485 certification work.
• Demonstrated IVD/medical device certification experience (20% weight): experience certifying in-vitro diagnostic (IVD) and/or medical device manufacturers of comparable size, complexity and regulatory environment. Scoring: 5 comparable clients = 20; 3-4 comparable clients = 15; 1-2 comparable clients = 8; none = 0. Evidence: reference letters or certification project records identifying IVD/medical device clients and scope.
• Competence of proposed ISO 13485 auditors (20% weight): 100% of proposed auditors must hold recognised medical device QMS auditor/lead auditor qualifications (e.g., IRCA or equivalent) and demonstrate competence to audit ISO 13485:2016. Scoring: all qualified with 5 years relevant experience = 20; all qualified with 3-<5 years = 15; partial team compliance = 8; insufficient evidence = 0. Evidence: CVs, auditor/lead auditor certificates, training records and evidence of relevant audit experience.
• Sector-specific competence of audit team (15% weight): the proposed audit team must demonstrate strong IVD-specific competence across the team, including understanding of applicable QMS and regulatory interfaces. Scoring: strong IVD-specific competence across team = 15; medical-device competence with some IVD exposure = 10; general medical-device exposure only = 5; no demonstrated sector competence = 0. Evidence: CVs, sector codes/competence records, training records and list of relevant audits performed.

Pricing format:

• Bidders must include a completed Annexure B with their submission.
• All prices must be quoted in South African Rand, inclusive of VAT.
• Any disbursement not specifically priced for will not be considered or accepted.
• Discounts will only be considered in the final evaluation stage if offered on an unconditional basis.
• Final pricing scores will be rounded to the nearest 2 decimal places.
• Delivery lead-time from date of purchase order must be stated.

Negotiation: If the price is not market-related, NHLS may negotiate a market-related price with the highest scoring respondent, then the second and third highest if needed, or cancel the RFQ.

Mandatory compliance:

• Bidder must be an accredited management system certification body with a valid scope of accreditation covering ISO 13485:2016, issued by SANAS or another accreditation body that is a signatory to the IAF Multilateral Recognition Arrangement (MLA). Evidence: valid accreditation certificate and current scope of accreditation.
• Registration on National Treasury's Central Supplier Database (CSD) is required; business may not be awarded to a respondent who has failed to register. Foreign suppliers with no local registered entity are exempt.
• Tax compliance: bidders must be tax compliant and submit a SARS Tax Compliance Status PIN or a printed TCS certificate. Where consortia/joint ventures/sub-contractors are involved, each party must submit a separate TCS certificate/PIN/CSD number.
• Bidders must not be persons in the service of the state, nor have directors/members who are.
• Bidders must not be listed on the Register for Tender Defaulters or the List of Restricted Suppliers.
• Compliance with the Employment Equity Act, including Section 53.
• DPIP/FPPO disclosure: bidders must complete the disclosure form and consent to processing of personal information under POPIA.
• Security clearance may be required to CONFIDENTIAL/SECRET/TOP SECRET level for the successful respondent, its personnel and subcontractors.
• Continued validity of returnable documents, including B-BBEE status, is required for the duration of any contract; failure to renew may result in termination.

Returnable forms (each must be completed and signed):

• SBD1 (Invitation to Bid): bidder and contact details, signed as the offer cover page.
• Section 5 (Certificate of Acquaintance with RFQ Documents): acknowledges familiarity with and acceptance of all RFQ conditions.
• Section 6 (RFQ Declaration and Breach of Law Form): certifies receipt of information, no undisclosed relationships with NHLS, and compliance with the Supplier Integrity Pact.
• Section 7 (Specific Goals Claim Form): claims preference points for specific goals under the 80/20 system.
• Section 8 (Protection of Personal Information): consents to processing of personal information.
• SBD4 (Bidder's Disclosure): declares whether any director/shareholder is employed by the state or connected to anyone at NHLS; failure to disclose all CSD-registered active companies linked to directors leads to disqualification.

Security clearance: Acceptance of the bid may be subject to the condition that the successful respondent, its personnel and subcontractors obtain security clearance from the appropriate authorities to the level of CONFIDENTIAL/SECRET/TOP SECRET. Obtaining the required clearance is the responsibility of the successful respondent. The successful respondent must also implement all security measures as the safe performance of the contract may require.

Contract terms:

• The successful respondent will be required to sign a written contract form (SBD7).
• The contract is proposed for a period of 5 years.
• The successful respondent must complete a Supplier Declaration Form for registration as a vendor on the NHLS vendor master database.
• The successful respondent must remain in full compliance with all applicable national and local laws and regulations.
• The successful respondent must maintain the validity of all returnable documents, including B-BBEE status, for the duration of the contract; failure to renew may result in immediate termination.
• NHLS may cancel the contract and request National Treasury to place the respondent on the Database of Restricted Suppliers for up to 10 years if the contract was awarded on the strength of incorrect information.
• The successful respondent must implement all security measures required for the safe performance of the contract.
• NHLS reserves the right to cancel the contract if the respondent fails to deliver within the quoted lead-time, and may recover expenses incurred in calling for fresh quotations.

Special conditions:

• Legal review of proposal by NHLS Legal Counsel; acceptance or rejection of proposed contractual terms and conditions.
• Security clearance may be required to CONFIDENTIAL/SECRET/TOP SECRET level for the successful respondent, its personnel and subcontractors.
• Compliance with the Employment Equity Act, including Section 53.
• Continued validity of returnable documents, including B-BBEE status, for the duration of the contract; failure to renew may result in termination.
• DPIP/FPPO disclosure and due diligence; NHLS will not conduct business with any respondent without considering governance protocols, determining DPIP/FPPO status, and conducting a risk assessment.
• NHLS reserves the right to cancel the contract and request National Treasury to place the respondent on the Database of Restricted Suppliers for up to 10 years if the contract was awarded on the strength of incorrect information.

Mandatory requirement: Bidder must be an accredited management system certification body with a valid scope of accreditation covering ISO 13485:2016, issued by SANAS or another accreditation body that is a signatory to the applicable IAF Multilateral Recognition Arrangement (MLA). Required evidence: valid accreditation certificate and current scope of accreditation explicitly covering ISO 13485:2016.

Evaluation methodology: Step 1 - Administrative responsiveness (timely submission, returnable documents completed, validity, signed by authorised respondent). Step 2 - Substantive responsiveness (general and legislation qualification criteria met, pre-qualification requirements, priced offer, material compliance with scope). Step 3 - Minimum threshold for technical criteria: mandatory requirement of accreditation of certification body (SANAS or IAF MLA signatory) covering ISO 13485:2016; functionality criteria with minimum threshold of 80 out of 100 points, including demonstrated ISO 13485 certification experience (25%), IVD/medical device certification experience (20%), competence of proposed ISO 13485 auditors (20%), sector-specific competence of audit team (15%), proposed certification methodology (10%), capacity and resources (5%), performance on comparable contracts (5%). Step 4 - Final weighted scoring: Price (80 points) using formula PS = 80(1 - (Pt - Pmin)/Pmin), Specific Goals (20 points). Step 5 - Post tender negotiations if price not market-related, sequential with highest ranked bidder. Step 6 - Award of business and conclusion of contract.

The National Health Laboratory Service (NHLS) requires appointment of suitably accredited and competent certification bodies to provide ISO 13485:2016 certification services for its Diagnostic Media Products (DMP) facilities. The evaluation distinguishes mandatory compliance requirements from scored technical functionality requirements.

Physical address: 1 Modderfontein Road, Sandringham, Johannesburg, South Africa

Postal address: Private Bag X8, Sandringham, 2131, South Africa

Telephone: +27 (0) 11 386 6000 / 0860 00 NHLS (6457)

Website: www.nhls.ac.za

Practice number: 5200296

Returnable documents: completed and signed SBD forms as applicable, including SBD 4 (Declaration of Interest) and SBD 9 (Certificate of Independent Bid Determination).

• Valid accreditation certificate and current scope of accreditation covering ISO 13485:2016.
• Company profile and verifiable reference letters/contracts confirming ISO 13485 certification work.
• Reference letters or certification project records identifying IVD/medical device clients and scope.
• CVs, auditor/lead auditor certificates, training records, and evidence of relevant audit experience for proposed auditors.
• Sector codes/competence records, training records, and list of relevant audits performed.
• Technical proposal covering certification methodology and implementation plan.
• Resource plan, auditor availability, geographic coverage, and proposed scheduling approach.
• At least three contactable client references, preferably from medical device/IVD organisations.

Disqualification risks:

• Failure to meet any mandatory pre-qualification requirement renders the bid technically non-responsive.
• Bids not satisfying all mandatory requirements will not proceed to functionality evaluation.

Evaluation stages:

1. Administrative compliance and accreditation requirements assessed first.
2. Functionality evaluation for bidders meeting all mandatory requirements.

Functionality scoring (total 100 points, minimum threshold 80 points):

• Demonstrated ISO 13485 certification experience (25%): ≥5 years with ≥5 relevant clients = 25; ≥5 years with 3-4 clients = 20; 3-<5 years with ≤3 clients = 15; <3 years or limited evidence = 5; no relevant evidence = 0.
• IVD/medical device certification experience (20%): ≥5 comparable IVD/medical device clients = 20; 3-4 = 15; 1-2 = 8; none = 0.
• Qualifications and competence of proposed ISO 13485 auditors (20%): 100% appropriately qualified with ≥5 years relevant experience = 20; all qualified with 3-<5 years = 15; partial team compliance = 8; insufficient evidence = 0.
• IVD/medical device technical competence of audit team (15%): strong IVD-specific competence = 15; medical-device competence with some IVD exposure = 10; medical-device exposure only = 5; no demonstrated sector competence = 0.
• Proposed certification methodology and implementation plan (10%): comprehensive, clear and fully responsive = 10; adequate with minor gaps = 7; partially responsive = 4; inadequate/no methodology = 0.
• Capacity and resources to provide certification services across required NHLS DMP facilities (5%): fully demonstrated capacity = 5; adequate but with limitations = 3; insufficient capacity = 0.
• Performance on comparable certification contracts (5%): 3 or more satisfactory references = 5; 2 = 3; 1 = 1; none = 0.

Minimum functionality threshold: 80 out of 100 points.

Scope: ISO 13485:2016 certification audit services for NHLS Diagnostic Media Products (DMP) facilities at four sites: Greenpoint, Sandringham, Port Elizabeth, and KwaZulu-Natal.

Audit requirements:

• Audit man-days to be determined by the SANAS approved service provider.
• Follow ISO 13485:2016 standard requirements for certification of the NHLS DMP laboratories.
• Assessments conducted at planned intervals as per each department plan or request.
• Cost for audit broken down per department, as audits will not be requested or conducted at the same time.
• Invoicing broken down by audit stages of the certification process.
• Assess the QMS for NHLS DMP X4 for ISO 13485:2016 requirements for activities outlined in tables 1-4.

Processes covered per site (as per tables):

• Management: quality policy, knowledge, customer requirements, historical performance, organogram, internal audits, non-conformances and corrective actions, document/record control procedures, management review, quality objectives, customer satisfaction.
• Resources: volume and revenue, organograms, capex/procurement process, MRM output, policy and procedure list, equipment asset list, equipment maintenance schedule, monthly report.
• DMP operations: customer order, planning of production, production, internal quality control and release of product, finished goods dispatch, daily production planning and volumes, QC daily production template information, released product.
• Measurement and analysis: data for quality objectives, performance evaluation, customer survey and feedback, internal audit schedule, MRM inputs.
• Improvement: data trends, nonconformity, customer feedback and survey, opportunities, quality objectives.
• Production: confirmation of raw material, product scheduling, printing of batch sheets, production of media and reagents.
• Quality assurance: collection of products and batch sheets, quality control, external quality control, appearance check, performance check, sterility check, release of products.
• Stores and distribution: capturing of released product, printing of picking notes, picking and packing, stock take, purchasing, dispatch, shipping.

Staff complement per unit:

• DMP Green Point: 0 corporate, 17 regional
• DMP Port Elizabeth: 0 corporate, 14 regional
• DMP Sandringham: 28 corporate, 0 regional
• DMP KwaZulu-Natal: 0 corporate, 14 regional

Technical proposal must cover certification methodology and implementation plan including Stage 1, Stage 2, surveillance and recertification activities; management of nonconformities; reporting; certification decision-making; and communication with NHLS. Must also describe approach to planning and coordinating audits across multiple DMP sites.

Bidder must demonstrate experience providing ISO 13485 certification services, with preference for at least five years' relevant certification experience. Must demonstrate experience certifying in-vitro diagnostic (IVD) and/or medical device manufacturers of comparable size, complexity and regulatory environment. Proposed auditors must hold recognised medical device QMS auditor/lead auditor qualifications (e.g., IRCA or equivalent) and demonstrate competence to audit ISO 13485:2016. Proposed audit team must demonstrate sector-specific competence relevant to medical devices and, preferably, IVD manufacturing, including understanding of applicable QMS and regulatory interfaces. Must demonstrate capacity to provide certification services across required NHLS DMP facilities within agreed timelines, including availability of suitably competent auditors. Must demonstrate satisfactory performance on comparable ISO 13485 certification contracts, preferably from medical device/IVD organisations.

Quality management system (QMS) to be assessed for ISO 13485:2016 compliance across four NHLS DMP facilities. Processes include management (quality policy, internal audits, non-conformances, document control, management review, quality objectives, customer satisfaction), production (raw material confirmation, batch sheets, media and reagent production), quality assurance (collection of products, quality control, external quality control, appearance/performance/sterility checks, release of products), and stores/distribution (picking, packing, stock take, purchasing, dispatch, shipping).

Pricing requirements:

• Cost for audit broken down per department, as audits will not be requested or conducted at the same time.
• Invoicing broken down by audit stages of the certification process.

No other financial requirements specified.

Mandatory pre-qualification:

• Bidder must be an accredited management system certification body with a valid scope of accreditation covering ISO 13485:2016 certification, issued by SANAS or another accreditation body that is a signatory to the applicable IAF Multilateral Recognition Arrangement (MLA).
• Required evidence: valid accreditation certificate and current scope of accreditation explicitly covering ISO 13485:2016 certification.

Additional technical conditions:

• Certification body must maintain its applicable ISO 13485 accreditation for the full duration of the contract.
• Auditors allocated to NHLS must be demonstrably competent for the assigned medical device/IVD scope and must be independent and impartial.
• Bidder should identify the proposed audit team and may not substitute key auditors without prior notification and evidence of equivalent competence.
• Certification approach must address the applicable certification cycle, including initial certification activities, surveillance and recertification.
• Audit reports must clearly document findings, nonconformities and the basis for certification decisions.
• Certification decisions must be made through the certification body's established independent certification decision process.
• Bidder must maintain confidentiality of NHLS information obtained during certification activities.
• Where multiple DMP facilities are included, bidder must describe its approach to planning and coordinating audits across the relevant sites.

Additional technical conditions: certification body must maintain applicable ISO 13485 accreditation for full contract duration. Auditors allocated to NHLS must be demonstrably competent for assigned medical device/IVD scope and independent and impartial. Bidder should identify proposed audit team and may not substitute key auditors without prior notification and evidence of equivalent competence. Certification approach must address applicable certification cycle including initial certification, surveillance and recertification. Audit reports must clearly document findings, nonconformities and basis for certification decisions. Certification decisions must be made through established independent certification decision process. Bidder must maintain confidentiality of NHLS information obtained during certification activities.